Handbook of adaptive designs in pharmaceutical and clinical development
By: edited by Annpey Pong, Shein-Chung Chow
Publisher: CRC Press
Published: 2011
Place of publication: Boca Raton, FL
Language: eng
ISBN-13: 9781439810163
Subjects: Research Design; Clinical trials; Drugs; Handbooks, manuals; Clinical Trials as Topic; Statistics as Topic; Methodology; Research; Methods
Description: "This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail include regulatory perspectives and logistics issues in applying adaptive design methods"--Provided by publisher.
Notes: Includes bibliographical references and index.
Table of contents: title: Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow; title: Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y. H. Chi; title: Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan; title: The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong; title: From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull; title: Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein; title: Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu; title: Adaptive interim analyses in clinical trials / Gernot Wassmer; title: Classical dose-finding trial / Naitee Ting; title: Improving dose-finding: a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong; title: Adaptive dose-ranging studies / Marc Vandemeulebroecke ... [et al.]; title: Seamless phase I/II designs / Vladimir Dragalin; title: Phase II/III seamless designs / Jeff Maca; title: Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong; title: Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger; title: Hypothesis-adaptive design / Gerhard Hommel; title: Treatment adaptive allocations in randomized clinical trials: an overview / Atanu Biswas and Rahul Bhattacharya; title: Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon; title: Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu; title: Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls / Independent data monitoring committees / Steven Snapinn and Qi Jiang; title: Targeted clinical trials / Jen-Pei Liu; title: Functional genome-wide association studies of longitudinal traits / Jiangtao Luo ... [et al.]; title: Adaptive trial simulation / Mark Chang; title: Efficiency of adaptive designs / Nigel Stallard and Tim Friede; title: Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee; title: Good practices for adaptive clinical trials / Paul Gallo.